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A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta

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ClinicalTrials.gov Identifier: NCT04253015
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
United BioSource, LLC
Information provided by (Responsible Party):
EusaPharma (UK) Limited

Brief Summary:
This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.

Condition or disease Intervention/treatment
Neuroblastoma Other: Data-collection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : March 31, 2032
Estimated Study Completion Date : June 15, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
Drug Information available for: Dinutuximab


Intervention Details:
  • Other: Data-collection
    Data will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs.


Primary Outcome Measures :
  1. Assessment of the severity of pain experienced by participants during treatment with dinutuximab beta [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Assessment of pain severity experienced by participants during the period of first dose of dinutuximab beta to the end of last 35 day course of 5th cycle of treatment

  2. Number of participants using analgesics during treatment with dinutuximab beta [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Use of analgesics during the period of first dose of dinutuximab beta to end of last 35 day course of 5th cycle of treatment

  3. Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions up to the end of the last 35 day course of 5th cycle of treatment

  4. Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) during treatment with dinutuximab beta [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) following the end of the last 35 day course of 5th cycle of treatment


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Overall Survival (OS) following the end of the last 35 day course of 5th cycle of treatment

  2. Progression free survival (PFS) [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Progression free survival (PFS) following the end of the last 35 day course of 5th cycle of treatment

  3. Event Free Survival (EFS) [ Time Frame: First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days) ]
    Event Free Survival (EFS) following the end of the last 35 day course of 5th cycle of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with high-risk neuroblastoma who are starting treatment with dinutuximab beta in the standard clinical practice setting or participating in a clinical trial where dinutuximab beta is provided according to the indication as per the country/regional marketing authorisation, provide consent/assent and are willing to be followed up for up to 10 years. Centers who treat neuroblastoma patients with dinutuximab beta will be invited to participate in the registry. This includes networks such as the Society of Paediatric Oncology for the Treatment of Neuroblastoma (SIOPEN) in Europe.
Criteria

Inclusion Criteria:

Patients meeting the following criteria will be considered for inclusion into the registry:

  • Patients diagnosed with high-risk neuroblastoma and starting treatment with commercially available dinutuximab beta OR
  • Patients diagnosed with high-risk neuroblastoma and starting treatment with dinutuximab beta in a clinical trial where dinutuximab beta is provided according to the country/regional marketing authorisation AND
  • Appropriate consent/assent has been obtained for participation in the registry with a willingness to be followed up for up to 10 years.

Exclusion Criteria:

Patient will not be eligible for inclusion if the following criterion applies:

  • Patients commencing dinutuximab beta within a clinical trial where the product is being provided outside of the country/regional marketing authorisation OR
  • Appropriate consent/assent has not been obtained for participation in the registry or patient/legal representative is not willing for the patient be followed up for up to 10 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253015


Contacts
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Contact: Jonathan Morgan, Dr +443305001140 Jon.Morgan@eusapharma.com

Locations
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Austria
St. Anna Kinderkrebsforschung Not yet recruiting
Wien,, Vienna, Austria, 1090
Contact: Ruth Ladenstein, Dr    +43(1)40470-4750    ruth.ladenstein@ccri.at   
Principal Investigator: Ruth Ladenstein, Dr         
France
Centre Oscar Lambret Not yet recruiting
Lille, France, 59000
Contact: Fabienne Dumont, Mr    +33 3.20.29.59.35    f-dumont@o-lambret.fr   
Principal Investigator: Anne-Sophie Defachelles, Dr         
Hôpital de la Timone, Hôpital des Enfants Not yet recruiting
Marseille, France, 13385
Contact: Sylvie Abed    00 33 4 91 38 68 21      
Principal Investigator: Carole Coze, Dr         
Institut Curie Not yet recruiting
Paris, France, 75005
Contact: Gudrun Schleiermacher, Dr    00 33 1 44 32 45 51    gudrun.schleiermacher@curie.fr   
Principal Investigator: Gudrun Schleiermacher, Dr         
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Imene Hazem, Mr    0033 1 42 11 50 20    Imene.HEZAM@gustaveroussy.fr   
Contact: Fanny Prenois, Mrs    0033 1 42 11 50 20    Fanny.PRENOIS@gustaveroussy.fr   
Principal Investigator: Dominique Valteau-Couanet, Dr         
Germany
Charité Berlin Recruiting
Berlin, Germany, 13353
Contact: Angelika Eggert, Dr    + 49 30 450 566 808    angelika.eggert@charite.de   
Contact: Heidi Deubzer, Dr    + 49 30 450 566 808    heidi.deubzer@charite.de   
Principal Investigator: Angelika Eggert, Dr         
Sub-Investigator: Heidi Deubzer, Dr         
Universitätsmedizin Greifswald Active, not recruiting
Greifswald, Germany, 17475
Uniklinik Köln Not yet recruiting
Köln, Germany, 50924
Contact: Thorsten Simon, Dr    +49 221-478-6850    thorsten.simon@uk-koeln.de   
Contact: Pablo Landgraf, Dr    +49 221-478-6850    pablo.landgraf@uk-koeln.de   
Principal Investigator: Thorsten Simon, Dr         
Sub-Investigator: Pablo Landgraf, Dr         
Sub-Investigator: Barbara Hero, Dr         
Italy
IRCCS Istituto Giannina Gaslini Recruiting
Genova, Italy, 16147
Contact: Sabrina Zanardi    +39.010.5636.3461    SabrinaZanardi@gaslini.org   
Principal Investigator: Carla Manzitti, Dr         
Sub-Investigator: Alberto Garaventa, Dr         
Sub-Investigator: Stefania Sorrentino, Dr         
Poland
Uniwersytecki Szpital Dziecięcy Recruiting
Kraków, Poland, 30-663
Contact: Aleksandra Wieczore, Dr    (+48) 12 3339392    a.wieczorek@uj.edu.pl   
Contact: Walentyna Balwierz, Dr    (+48) 12 658 20 11 ext 4321    walentyna.balwierz@uj.edu.pl   
Principal Investigator: Aleksandra Wieczorek, Dr         
Sub-Investigator: Walentyna Balwierz, Dr         
Spain
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell Recruiting
Valencia, Spain, 46026
Contact: Desiree Ramal    +34-638902615      
Principal Investigator: Adela Canete, Dr         
Sub-Investigator: Antonio Juan Fornes, Dr         
Sub-Investigator: Blanca Martinez, Dr         
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust Not yet recruiting
Newcastle Upon Tyne, Newcastle, United Kingdom, NE1 4LP
Contact: Geoff Bell    0191 282 1337    Geoff.Bell@nuth.nhs.uk   
Contact: Linda Coates    0191 2829964    Linda.Coates7@nhs.net   
Principal Investigator: Deborah Tweddle, MD         
Birmingham Children's Hospital Active, not recruiting
Birmingham, United Kingdom, B4 6NH
University Hospital Southampton Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Ruth Lawrence    02381206334    Ruth.Lawrence@uhs.nhs.uk   
Contact: Alice Johnson    02381206334    alice.johnson@uhs.nhs.uk   
Principal Investigator: Juliet Gray, Dr         
Sub-Investigator: Sucheta Vaidya, Dr         
Sponsors and Collaborators
EusaPharma (UK) Limited
United BioSource, LLC
Investigators
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Study Director: Jonathan Morgan, Dr EUSA Pharma (UK) Limited
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Responsible Party: EusaPharma (UK) Limited
ClinicalTrials.gov Identifier: NCT04253015    
Other Study ID Numbers: EUSA DB 0001
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EusaPharma (UK) Limited:
Tumour
Brain tumour
Paediatrics
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue